NCT04974229

Brief Summary

A longitudinal observational cohort study to investigate the value of prognostic factors, here sensory profiles , and others, in the development of central sensitization in the low back pain population. A type 2 prognostic factor research following the PROGRESS framework. Sensory profiles are identified a prognostic factors which can predict the development of central sensitization in the low back pain population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

July 6, 2021

Last Update Submit

July 21, 2021

Conditions

Sensory ProfilesCentral SensitisationLow Back PainNociplastic Pain

Keywords

Prognostic factors researchSensory ProfilesCentral SensitisationLow back painNociplastic Pain

Outcome Measures

Primary Outcomes (2)

  • Central Sensitization Inventory score

    The validated questionnaire Central Sensitization Inventory which scores on a 5 point scale ranging from 0-100. A higher score indicated a higher degree of central sensitization.

    12 weeks

  • Adolescent/Adult Sensory Profile score

    Adolescent/Adult Sensory Profile measures 4 sensory profiles (sensation avoiding, sensation sensitive, sensation seeking, low registration) on ad 5 point scale, and is validated in the low back pain population. Scores range from 15-60 points per variable. A higher score means a higher degree of sensitivity for the specific sensory profile.

    0 weeks

Secondary Outcomes (4)

  • Numeric Pain Rating Scale score

    Baseline (0 weeks)

  • Pain Disability Index score

    Baseline (0 weeks)

  • age

    Baseline (0 weeks)

  • duration of low back pain

    Baseline (0 weeks)

Study Arms (1)

acute non-specific low back pain

patients with acute low back pain of (\< 6 weeks) were consecutively included with or without radiating pain, aged 18 to 60 years with a pain-free episode for at least 3 months before the onset of their current back pain. They were also required to be able to read and understand the Dutch language.

Other: In line with the Dutch guideline for non-specific low back pain, Standard usual care for non-specific low back pain was applied.

Interventions

In line with the Dutch guideline for non-specific low back pain, Standard usual care for non-specific low back pain was applied.OTHER

In line with the Dutch guideline for non-specific low back pain, Standard usual care or non-specific low back pain was applied.

Also known as: In line with the Dutch guideline for low back pain, Standard usual care or non-specific low back pain was applied.
acute non-specific low back pain

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants were recruited primary care physiotherapy practices randomly spread throughout the Netherlands. Participants with acute low back pain were consecutively included by physiotherapists.

You may qualify if:

  • acute low back pain (\< 6 weeks)
  • with or without radiating pain
  • aged 18 to 60 years
  • a pain-free episode for at least 3 months before the onset of their current back pain
  • read and understand the Dutch language.

You may not qualify if:

  • previous lumbar spinal surgery
  • lumbar radicular syndrome
  • specific cause of low back pain
  • lumbar spinal stenosis
  • current malignancy
  • spondyloarthropathy
  • osteoporosis
  • spondylolisthesis
  • major trauma
  • infection
  • systemic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije universiteit Brussel

Brussels, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

patients with acute low back pain (\< 6 weeks) were consecutively included with or without radiating pain, aged 18 to 60 years with a pain-free episode for at least 3 months before the onset of their current back pain. They were also required to be able to read and understand the Dutch language.

MeSH Terms

Conditions

Low Back PainNociplastic Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aldo Scafoglieri, PhD

    VUB

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 23, 2021

Study Start

January 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)